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Lisbert Avila-Yu Location
Hialeah, FL, US
Lisbert Avila-Yu Work
Vice President of Regulatory Affairs and Quality Assurance @ (November 2020 - Present)
Senior Director of Regulatory Affairs @ (November 2019 - November 2020)
Director of Regulatory Affairs @ (September 2017 - November 2019)
AIMD Project Manager and Technical Specialist @ (March 2016 - September 2017)
Associate Director of Regulatory Affairs @ (March 2014 - March 2016)
Regulatory Affairs Manager @ (April 2010 - March 2014)
Regulatory Professional @ Regulatory (January 2016 - December 2016)
Presenter @ RAPS Annual Conference (January 2013 - October 2015)
RA @ (January 2000 - December 2010)
Lab Assistant @ (January 1999 - December 2000)
Lisbert Avila-Yu Education
Duke University
(Lambda Pi Chi Sorority)
1996-2000
Lisbert Avila-Yu Skills
Design Control
ISO 13485
ICH-GCP
Hospitals
FDA
Biotechnology
Medical Devices
Regulatory Affairs
CAPA
Quality System
Regulatory Submissions
V&V
ISO 14971
Validation
GMP
Change Control
21 CFR
21 CFR Part 11
Biomedical Engineering
FDA GMP
Medical Device Directive
CE marking
CQA
Regulatory Requirements
Leadership
Ich Gcp
PowerPoint
Public Speaking
SQL
Management
Project Management
Research
Lisbert Avila-Yu Summary
Lisbert Avila-Yu, based in Hialeah, FL, US, is currently a Vice President of Regulatory Affairs and Quality Assurance at Endotronix. Lisbert Avila-Yu brings experience from previous roles at Endotronix, BSI and HeartWare Inc.. Lisbert Avila-Yu holds a 1996 - 2000 Duke University. With a robust skill set that includes Design Control, ISO 13485, ICH-GCP, Hospitals, FDA and more. Lisbert Avila-Yu has 1 emails on RocketReach.
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